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General MedicationsINTRAMUSCULARStandard

INVEGA HAFYERA

PALIPERIDONE PALMITATE

Standard Dose
1.092GM/3.5ML (312MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview INVEGA HAFYERA is listed in Drugs@FDA under application 207946 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PALIPERIDONE PALMITATE Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 1.092GM/3.5ML (312MG/ML) Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2025-01-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview INVEGA HAFYERA is listed in Drugs@FDA under application 207946 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PALIPERIDONE PALMITATE Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 1.092GM/3.5ML (312MG/ML) Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2025-01-23 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.